January 26, 2006
Study finds kidney risks in Bayer’s Trasylol
Research being published in the New England Journal of Medicine today concluded that use of Bayer’s Trasylol (aprontin), a standard treatment to limit blood loss during heart surgeries, were at an increased risk of kidney failure, heart attacks and strokes, compared with patients taking alternative drugs, aminocaproic acid and tranexamic acid, or no drugs at all. The study of 4,374 patients also found that the cheaper alternatives to Trasylol were just as effective in limiting blood loss but didn't cause any of the dangerous side effects associated with the more expensive brand medication. According to the study, 8% of the 1,295 patients receiving Trasylol suffered kidney dysfunction or required dialysis, which was twice the rate of the 1,705 patients receiving the generic drugs. In the first nine months of last year, Trasylol was Bayer's fastest-growing drug, with global sales of just under $200 million. Bayer says 150,000 patients received the drug in the US during 2005. In a statement, the FDA called the study “complicated analysis based on a large observational database.” The agency said it is working to gather all available information and to evaluate the drug's safety and “will make recommendations for best use as soon as possible.” The Ischemia Research and Education Foundation in San Bruno, Calif., a nonprofit foundation known for studying heart attacks and strokes, sponsored the study. The foundation’s chief executive and lead author of the study, Dennis Mangano, told The Wall Street Journal, the foundation's funding comes from its endowment, built by doing clinical-trial work for drug companies in the 1990s. He says the group no longer does that work for drug companies.